Vaccines, Blood & Biologics
Resources for You
Biologics Guidances
Guidance documents describe FDA’s interpretation of or policy on a regulatory issue (21 CFR 10.115(b)). These documents usually discuss more specific products or issues that relate to the design, production, labeling, promotion, manufacturing, and testing of regulated products. Guidance documents may also relate to the processing, content, and evaluation or approval of submissions as well as to inspection and enforcement policies. Guidance documents are not regulations and alternative approaches may be chosen to comply with laws and regulations.
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.
Biologics
General
Other Topic Area Guidances
- Guidance for Industry
Animal & Veterinary - Guidance Documents
Combination Products - Guidance Documents
Cosmetics - Guidances (Drugs)
Drugs - Guidance Documents
Food - Guidance Documents (Medical Devices)
Medical Devices - Industry Guidance
Radiation-Emitting Products
Subscribe to Updates
Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448